Comparing metformin addition to standard care after bariatric surgery for diabetes remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled, open-labeled, multicenter trial evaluates whether adding metformin to standard care can extend the duration of diabetes remission in adults who have undergone bariatric surgery. Participants will be adults aged 18-70 who had gastric bypass or sleeve gastrectomy 12 to 36 months prior and have achieved an HbA1c of less than 6.5% without anti-hyperglycemic medications. The study aims to address the significant number of patients who experience a return of diabetes after surgery, as current interventions to prolong remission have not been explored. By comparing outcomes between those receiving metformin and those receiving standard care, the trial seeks to provide insights into effective post-surgical diabetes management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults 18-70 years old
* Having undergone gastric bypass or sleeve gastrectomy 12 to 36 +/-3 months before inclusion
* "ex-T2D" treated with at least one anti-diabetic drug before bariatric surgery or HbA1c ≥ 6.5 % before bariatric surgery
* HbA1C \< 6.5 % at inclusion with no anti-hyperglycemic medications for the last three months
* Written consent

Exclusion Criteria:

* Known type 1 diabetes
* Pregnancy and breastfeeding
* Estimated glomerular filtration rate\<44 ml/min (MDRD)
* Known intolerance to metformin
* Known contraindication to metformin:

  * Acute metabolic acidosis
  * Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours)
  * Acute or chronic disease which could lead to a tissue hypoxia (ex : severe cardiac insufficiency, severe respiratory insufficiency, myocardial infarction within the last 3 months, shock)
  * Hepatocellular insufficiency
  * Prothrombin ratio ≤ 50%
  * SGOT or SGPT levels ≥ 10 times the upper limits of the normal range
  * Alcohol use disorder
* Medications and medical conditions likely to confound the assessment of diabetes:

  * glucocorticoids treatment
  * renal graft
  * Cushing's syndrome
  * acromegaly
  * fasting plasma triglyceride \> 600 mg/dl despite treatment
* Patient under legal protection

Where it's running

• CHU Amiens-Picardie - hôpital Nord
  Amiens, France Recruiting
• CHU de Bordeaux - hôpital Haut-Lévêque
  Bordeaux, France Recruiting
• AP-HP - hôpital Ambroise-Paré
  Boulogne-Billancourt, France Recruiting
• AP-HP - hôpital Louis-Mourier
  Colombes, France Recruiting
• Centre hospitalier intercommunal de Créteil
  Créteil, France Recruiting
• CHU de Lille - hôpital Claude Huriez
  Lille, France Recruiting

Study contacts

• Principal investigator: Claire CARETTE, MD — claire.carette@aphp.fr
• Study coordinator: Aurélie GUIMFACK
• Email: aurelie.guimfack@aphp.fr

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.